PROJECT SUMMARY Biobank Core The overarching mission of the WU-DDRCC is to promote collaborative, multidisciplinary research focused on interactions between host and environment in digestive disease. The Biobank Core promotes clinical translational research across a spectrum of digestive diseases by (1) Assisting members in navigating the evolving institutional review board (IRB) guidelines for human research; (2) Assembling a qualified team of personnel to identify and consent patients, collect and store clinical metadata, collect, process and store specimens for high quality, high throughput analysis; (3) Acquiring the physical resources to store and rapidly retrieve specimens and clinical metadata; (4) Developing pipelines for high quality and high fidelity downstream analysis; (5) Collecting enough patients/specimens to have statistically robust and meaningful outcomes for a given research project. Accomplishments since 2013 include: (1) Established and maintained an open IRB protocol with a one-time lifetime consent allowing the broad collection and sharing of specimens and their derivatives linked with clinical data. (2) Identified, trained, and retained personnel to maintain the IRB protocols, recruit patients, collect, process, store, and retrieve specimens, and collect and maintain clinical data for DDRCC members. (3) Developed pipelines to rapidly obtain high quality and high fidelity genetic, microbial metagenomic, and gene expression data on patient specimens. (4) Developed material transfer agreement protocols to allow specimens and data to be efficiently shared. (5). Enrolled over 6,500 patients from over 14 digestive disease categories as of 10/01/2018. (6) Collected over 18,000 specimens with clinical metadata, performed extensive genotype analysis on over 2,400 patients as of 10/01/2018. (7) Established relationships with the human studies committee allowing the Biobank to write, execute, and maintain over 20 IRB protocols for DDRCC members in a rapid, efficient, and cost effective manner. The Biobank Core supported 24 DDRCC investigators including 8 ongoing prospective collections, resulting in 58 peer reviewed publications (42/58 with 2 members) citing the DDRCC. In addition, the Biobank Core promotes and participates in consortium studies in human digestive disease involving institutions (including other DDRCCs) throughout the United States. The Biobank Core will continue to promote, facilitate, and accelerate basic and clinical-translational observational studies of human digestive disease. Based upon these accomplishments and to continue to pursue this mission we propose the following specific aims: Aim 1: Develop and maintain an archival specimen set linked with clinical metadata to rapidly support retrospective studies and jump start prospective studies of human digestive disease by DDRCC members; Aim 2: Develop and maintain the infrastructure to support and rapidly and efficiently execute prospective studies in human digestive disease by DDRCC members; Aim 3: Develop and maintain the infrastructure to support large observational studies of human digestive disease across multiple institutions (including other DDRCCs) throughout the United States.